FDA recall Z-3213-2024

Product

prodisc C SK, Total cervical disc replacement, Model/Catalog Number: PDSM5

Reason for recall

During the assembly of Prodisc C, a blue discoloration was observed on a Prodisc C inlay. The discoloration is considered a foreign contaminate that may not have been fully evaluated in the manufacturing validations.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2024-07-18

Report date

2024-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3213-2024